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Capitol Comment 150 - The FDA's Party Patrol

For every Food and Drug Administration employee who approves life-saving new drugs for patient use, there are more than two FDA employees who scour the countryside looking for regulatory violations. These regulatory cops may or may not do anything to help patients, but some of them have found a new professional interest: bar hopping.

However, these federal agents are not out for a good time. They are on the lookout for something the FDA considers the latest threat to public health: laser light shows. In clubs, concert halls, carnivals and churches across America, performers are using dramatic laser light displays to entertain their audiences. This federal agency fears that unless federal regulation comes to the rescue, a mismanaged laser light show may damage someone's eyesight.

This has led FDA agents to patrol discotheques and concert halls across America, looking for special effects violations. Agents will often wade through a crowd of party-goers, any number of whom may be buying, selling and abusing actual drugs, only to take out a measuring tape and make sure the special effects equipment is the proper distance from the floor.

In fact, the FDA has also begun regulating any device that uses lasers, including bar code scanners in grocery store check-out lines and compact disc players, despite the fact that private sector organizations (such as Underwriter's Laboratories, Inc.) have been certifying the safety of electronic devices longer than the FDA has been in existence.

Earlier this year, FDA agents crashed a "rave" in San Francisco. (For the uninitiated, "raves" are parties known for loud music and heavy drug use.) After wading through that crowd, FDA agents discovered the laser beams used in the light show were not the minimum three meters above the floor.

Busted. The light show operator later was alerted to this violation in a "warning letter" from the FDA. (FDA warning letters have been known to strike fear in the hearts of the world's most powerful CEOs.) Other violations listed in the warning letter were that the light show operator did not receive written permission from the FDA to put on the show, and that he did not tell the FDA about the show in advance. The letter advised the light show operator that if he fails to heed the agency's demands, he will face $1,000 fines and jail time for every show he stages.

What laser light shows have to do with food and drugs is anyone's guess, yet the sheer silliness of its pursuit has not deterred the FDA Party Patrol. So far this year, FDA bloodhounds have crashed as many as 60 parties across the country looking for special effects violations, handing out nearly a dozen warning letters.

If the FDA is to regulate theater, certainly there are other dangers to consider. Eye damage is not the only threat to club-goers. Wherever there is a laser light show, there is usually a deafening sound system. Such sound systems pose a serious threat to any nearby eardrum. Should the FDA regulate how far speakers must be set back from the dance floor? Why not require discotheques to notify the FDA before they throw any loud parties? Alcoholic beverages pose a risk to bar-goers. Should the FDA require them to keep a safe distance away from their drinks?

Arguably, mismanaged light shows can cause eye damage. So can the sun, for that matter. The safety of light shows and compact disc players is not the issue. Rather, the issue is that the FDA is willing to make patients wait longer for potentially life-saving new treatments so that it may engage in activities that have nothing to do with food or drugs and duplicate private sector efforts.

Every penny the FDA spends going to parties and regulating special effects means less money for new cancer and AIDS treatments. Until the FDA approves a new medicine for cancer or AIDS, patients can't use it, and the FDA is notorious for making patients wait for new medicines. On average, the FDA takes 15 years to approve a new drug. It often takes longer. (In contrast, that San Francisco special effects technician only had to wait two months for his warning letter.) Spaceships have left the solar system in less time than it takes the FDA to approve one new drug. The FDA's folly would be amusing if the tradeoff were not so tragic.

Does the public really need to have FDA agents at discotheques with a tape measure to ensure that laser beams are the proper height off the ground? Do we really want the FDA handing out $1,000 fines and jail time because, essentially, they weren't invited to the party?

The FDA is not doing its job, yet it continues to divert taxpayer dollars away from the approval of new medicines toward regulatory pursuits that don't even pass the giggle test. This happens largely because every year, Congress gives the FDA a lump sum of money which the FDA is allowed to spend as it pleases. It is time for Congress to tighten the reins on this errant federal agency.